A women's gel with vaginal tightening effect and its preparation method and application

Abstract

The present application belongs to the technical field of gynecological external medicine, and particularly relates to a gynecological gel with a vagina tightening effect and a preparation method and application thereof. The gel comprises the following components in parts by weight: gallic acid 0.1-1 parts and dimethyl sulfone 0.2-1 parts. The gynecological gel is prepared by compounding gallic acid and dimethyl sulfone at a specific ratio. The antioxidant and antibacterial effects of gallic acid and the deep repair and penetration characteristics of dimethyl sulfone can play a synergistic effect. The gynecological gel can not only effectively solve the problem of vaginal relaxation, but also provide a mild, safe and long-acting care solution for women, help restore vaginal health and tightness, maintain the microecological balance of the vagina, and meet the needs of modern women for health and care.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of gynecological external drugs, and particularly relates to a gynecological gel with a vaginal tightening effect and a preparation method and application thereof. BACKGROUND

[0002] Vaginal relaxation is a common problem caused by various factors such as age growth, postpartum recovery, hormone changes, etc. in women. The existing vaginal tightening products mainly rely on physical means to achieve short-term effects, which is difficult to fundamentally solve the relaxation problem, and some products may have a negative impact on the vaginal microecology, leading to infection or dysbiosis.

[0003] However, the effect of this kind of method is usually short-term, and the tightening feeling disappears quickly with local metabolism or tissue recovery, which cannot fundamentally improve the problem of vaginal relaxation.

[0004] The vaginal water light needle (tightening needle) in medical beauty technology can moisturize and enhance elasticity by injecting hyaluronic acid, collagen and other active ingredients, promote collagen production and tissue regeneration in the short term, and provide more significant tightening effect. However, the effect of this method is also limited, usually needs regular injection to maintain, and the cost is high, which cannot long-term cure the problem of vaginal relaxation.

[0005] CN202320573371.3 patent claims that its vaginal tightening rehabilitation device with electric shock and vibration function can quickly stimulate vaginal muscles through the combination of electric shock and vibration, help to restore tightness, and has no harm to the body. However, there is not enough evidence to verify its safety and effectiveness, which cannot guarantee that the device is suitable for all people, and may have side effects on sensitive users. In addition, the complexity of the device and the electric shock function may cause discomfort, and its clinical application value is not clear.

[0006] CN201922078575.6 patent discloses a shrinking ball connected with a soft handle and a spherical body, the spherical body has rhombic convex patterns, and the inside is provided with a replaceable steel ball with adjustable weight, which is claimed to achieve tightening effect through physical means and relieve dryness problem, and is convenient to use and suitable for shrinking exercise at any time. However, the shrinking ball needs to be inserted correctly, the weight needs to be adjusted, and it needs to be used regularly, which is relatively complex for users to master. Secondly, the shrinking ball needs to be cleaned and maintained regularly, and it is not easy to use in public places. In addition, the shrinking ball belongs to an invasive physical shrinking method, which may cause discomfort or potential harm to sensitive women. For some women with certain health conditions or sensitive constitution, there may be potential risks in use.

[0007] CN202311623430.4 patent discloses a shrinkage lubricating gel, mainly through the components such as xanthan gum, trehalose, glycerol, gelatin alginate complex, to form a protective bio-gel layer on the vaginal wall, claiming to prevent pathogenic microorganisms from colonizing, and improve symptoms such as vaginal itching and erosion. However, this patent focuses on the physical barrier and lubrication function, and does not provide an effective solution for vaginal tightening.

[0008] Therefore, the existing technology for vaginal contraction and tightening still has the following disadvantages: (1) short-acting: physical contraction products can only provide short-term tightening effect, usually need to be used frequently to maintain the effect, and cannot solve the problem of vaginal relaxation for a long time; (2) destroy the microecological environment: some physical tightening products contain chemical ingredients, which may destroy the natural acid-base balance of the vagina, leading to dysbiosis, thus causing private discomfort, itching, odor, and even increasing the risk of infection; (3) lack of repair function: traditional physical tightening products are mostly emergency products, which cannot effectively repair the damage to the vaginal mucosa caused by relaxation or aging, and are also difficult to promote tissue regeneration and elastic recovery. Therefore, there is an urgent need in the market for a product that can provide long-term repair, gentle tightening and safety. SUMMARY

[0009] The purpose of the present application is to overcome the shortcomings of the prior art and provide a women's gel with vaginal tightening effect and its preparation method and application, aiming to fundamentally solve the problem of vaginal relaxation.

[0010] To achieve the above purpose, the technical solution adopted by the present application includes:

[0011] In a first aspect, the present application provides a women's gel with vaginal tightening effect, which comprises the following components by weight: gallic acid 0.1-1 part and dimethyl sulfone 0.2-1 part.

[0012] Gallic acid, as a natural polyphenolic substance, has antioxidant, antibacterial and tissue repair functions. Its introduction into vaginal care products can help restore the elasticity of the mucosa and provide long-term tightening and repair effects.

[0013] Methylsulfonylmethane (MSM for short) has the molecular formula C2H6O2S and is a natural organic sulfur compound widely found in animals and plants. It is often used as a dietary supplement and skin care ingredient. Its excellent bioavailability and penetration allow it to quickly penetrate the skin barrier, accelerating the absorption of active ingredients such as gallic acid, thereby enhancing the overall product efficacy. In addition, MSM has good anti-inflammatory and antioxidant properties, which can effectively relieve local inflammation and reduce tissue damage, making it particularly suitable for repairing tissues in sensitive areas. At the same time, it can promote the synthesis of collagen and keratin, helping to repair and strengthen tissue structure, which is crucial for improving the firmness and elasticity of vaginal mucosa. Moreover, the cell regeneration-promoting effect of MSM not only accelerates tissue repair but also maintains the moisture balance of the mucosa, thereby improving the moisturizing effect of the local area and further enhancing the overall firmness.

[0014] Through experimental exploration, it was found that the antioxidant and antibacterial effects of gallic acid and the deep repair and penetration properties of methylsulfonylmethane can exert a synergistic effect. When combined, the two components work together to not only effectively address vaginal relaxation but also provide a gentle, safe, and long-lasting care solution for women, helping to restore vaginal health and firmness while maintaining the microecological balance of the vagina. When either component is missing or replaced, the repair and firmness effect of the gel will be significantly reduced.

[0015] Furthermore, when the inventors explored the dosage ratio of the two components, it was found that when the ratio of gallic acid and methylsulfonylmethane exceeds the preferred range of the present invention, the synergistic effect between the components is not obvious or even antagonistic, resulting in a significant decrease in the firmness and repair efficacy of the gel. This indicates that the two components have an ideal synergistic effect within the limited range of the present invention.

[0016] Preferably, the gel includes the following components in parts by weight: 0.1-0.4 parts of gallic acid and 0.2-0.5 parts of methylsulfonylmethane.

[0017] Preferably, the gel includes the following components in parts by weight: 0.2 parts of gallic acid and 0.4 parts of methylsulfonylmethane.

[0018] Through experimental exploration, it was found that when gallic acid and methylsulfonylmethane are compounded at the above optimal dosage ratio, the elastin expression rate of the prepared gel is greatly improved in zebrafish experiments, effectively restoring the elasticity of the mucosa and providing long-term firmness and repair effects, fundamentally improving the problem of vaginal relaxation, and achieving the best synergistic effect.

[0019] Preferably, the gel further includes the following components in parts by weight based on 100 parts by weight: 1-5 parts of a humectant, 0.1-1 parts of a thickening agent, 0.2-0.5 parts of a neutralizing agent, and the balance of water.

[0020] Preferably, the gel further comprises the following components by weight parts per 100 parts by weight: humectant 3 parts, thickening agent 0.5 parts, neutralizing agent 0.2-0.5 parts, and the balance water.

[0021] Preferably, the humectant comprises glycerol and 1,2-hexanediol, and the mass ratio of the glycerol and 1,2-hexanediol is (1.5-2.5):1.

[0022] Preferably, the humectant comprises glycerol and 1,2-hexanediol, and the mass ratio of the glycerol and 1,2-hexanediol is (1.8-2.2):1.

[0023] More preferably, the humectant comprises glycerol and 1,2-hexanediol, and the mass ratio of the glycerol and 1,2-hexanediol is 2:1.

[0024] The present application further adds specific amounts of glycerol and 1,2-hexanediol in the gel, both of which are humectants that can further improve the moisturizing effect of the gel, fully achieve the water balance of the mucous membrane, and thus enhance the overall tightening repair effect of the gel to a certain extent.

[0025] Preferably, the thickening agent comprises carbomer U30; and / or, the neutralizing agent comprises sodium hydroxide.

[0026] In a second aspect, the present application provides a preparation method of the gel for women, which comprises the following steps:

[0027] S1, adding a thickening agent into water to swell, to obtain a swelling solution;

[0028] S2, mixing a humectant, gallic acid, dimethyl sulfone, and water to obtain a mixed solution, and then adding the mixed solution into the swelling solution and stirring for 10-30 min;

[0029] S3, further adding a neutralizing agent to adjust the pH value to 5.0-6.2, to obtain the gel for women.

[0030] In a third aspect, the present application provides use of the gel for women in preparation of a vaginal tightening or repair product.

[0031] Preferably, the mass percentage content of the gel for women in the vaginal tightening or repair product is 0.05-0.15%. It is found through exploration that the gel has the best effect in enhancing the expression of elastin gene when the dosage is 0.1%, and the expression promotion rate is close to that of the positive drug group.

[0032] Compared with the prior art, the present application has the following beneficial effects:

[0033] The application adopts gallic acid and dimethyl sulfone to prepare a gel for women in a specific ratio, and the antioxidant and antibacterial effects of gallic acid and the deep repair and penetration characteristics of dimethyl sulfone can play a synergistic effect, which can not only efficiently solve the problem of vaginal relaxation, but also provide a mild, safe and long-acting care solution for women, help to restore vaginal health and tightness, maintain the microecological balance of the vagina, and meet the needs of modern women for health and care. BRIEF DESCRIPTION OF DRAWINGS

[0034] Fig. 1 It is a comparison chart of the results of the chicken embryo mucosa stimulation experiment of the negative control (NC) in effect example 2, the left chart is before adding the sample, and the right chart is after adding the sample;

[0035] Fig. 2 It is a comparison chart of the results of the chicken embryo mucosa stimulation experiment of the negative control (PC) in effect example 2, the left chart is before adding the sample, and the right chart is after adding the sample;

[0036] Fig. 3 It is a comparison chart of the results of the chicken embryo mucosa stimulation experiment of the test sample (example 1) in effect example 2, the left chart is before adding the sample, and the right chart is after adding the sample. DETAILED DESCRIPTION

[0037] In order to better illustrate the purpose, technical scheme and advantages of the present application, the present application will be further described below in combination with specific examples. Those skilled in the art should understand that the specific examples described herein are only used to explain the present application and do not limit the present application.

[0038] Unless otherwise specified, the raw materials involved in the following examples and comparative examples are commercially available general raw materials.

[0039] Examples 1-5

[0040] Examples 1-5 provide a gel for women with vaginal tightening effect, and the specific formula is shown in Table 1 (total weight parts are 100 parts). The preparation method of the gel for women includes the following steps:

[0041] S1, adding a thickening agent to water to swell, to obtain a swelling solution;

[0042] S2, mixing a humectant, gallic acid, dimethyl sulfone and water to obtain a mixed solution, and then adding the mixed solution to the swelling solution and stirring for 10-30 min;

[0043] S3, adding a neutralizing agent to adjust the pH value to 5.0-6.2, to obtain the gel for women.

[0044] Table 1 Formulation table of the gel for women in examples 1-5 (weight parts)

[0045]

[0046] Comparative Examples 1-5

[0047] The present application also provides the formula of the feminine gel of Comparative Examples 1-5, as shown in Table 2 (total weight parts are 100 parts). The preparation method of the feminine gel provided by Comparative Examples 1-5 is similar to that of Examples 1-5, except that the formula is different.

[0048] Table 2 Formula table of the feminine gel of Comparative Examples 1-5 (weight parts)

[0049]

[0050]

[0051] Comparative Example 6

[0052] The present comparative example provides a feminine gel, which is only different from Example 1 in that hyaluronic acid is replaced by gallic acid, and the rest of the components and contents are the same.

[0053] Comparative Example 7

[0054] The present comparative example provides a feminine gel, which is only different from Example 1 in that α-lipoic acid is replaced by dimethyl sulfone, and the rest of the components and contents are the same.

[0055] Effect Example 1

[0056] The present effect example tests the tightening effect of the sample on the vagina through the zebrafish tightening efficacy experiment, and the specific method is as follows.

[0057] The feminine gels prepared by Examples 1-5 and Comparative Examples 1-7 are tested as samples, the concentration of the sample in the working solution is 0.1%, and a blank control group and a positive drug group (0.8 g / L) are additionally set. Each group has 3 biological replicates, each replicate sets 10 fish, and 5 mL of working solution is added to each well; after incubation in a constant temperature incubator at 28.5±0.5℃ for 24 h, the sample is taken; total RNA extraction, reverse transcription and fluorescence quantitative PCR amplification are performed on each group of zebrafish, β-actin gene is used as an internal reference gene, and the relative expression amount of each group of elastin gene is calculated by using 2 -△△Ct Method, the gene expression promotion rate of the test group relative to the control group is calculated, the final result of each group is averaged, and the results are shown in Table 3.

[0058] Table 3 Relative expression amount of zebrafish elastin

[0059]

[0060]

[0061] As can be seen from the results in Table 3, the gel prepared by the technical scheme of the present application can significantly promote the expression of elastin gene, thereby helping to improve the tightness and elasticity of the vaginal mucosa, achieving the vaginal tightening effect, and the gel prepared in Example 1 has the highest gene expression promotion rate, i.e. the best tightening effect.

[0062] However, in Comparative Examples 1-2, gallic acid and dimethyl sulfone are respectively absent, and the relative expression amount and promotion rate of the gel prepared for the elastin gene are significantly lower than those of the examples, indicating that the synergistic effect of gallic acid and dimethyl sulfone plays an important role in the expression of the elastin gene. When any component is missing, the gene expression promotion rate of the gel significantly decreases, and when the two components are replaced by other components with similar effects in Comparative Examples 6-7, the relative expression amount of the gel for the elastin gene also significantly decreases, indicating that gallic acid and dimethyl sulfone cooperate with each other and can synergistically enhance the tightening effect of the gel. However, when other components are used for conventional replacement, the synergistic effect is not obvious. In Comparative Examples 4-5, the amount of gallic acid and dimethyl sulfone exceeds the limited range of the present application, and the gene expression promotion rate of the gel also significantly decreases, i.e. the imbalance of the ratio of the two components will weaken the tightening effect of the gel. The above results all indicate that gallic acid and dimethyl sulfone can better play a synergistic effect within a specific amount range, significantly improve the vaginal repair and tightening effect of the gel, and thereby efficiently solve the problem of vaginal relaxation.

[0063] Effect Example 2

[0064] In this effect example, the gel prepared in Example 1 is used as a sample, and the irritation of the sample to the vaginal mucosa is tested by a chicken embryo mucosa irritation experiment. The specific method is as follows.

[0065] Preparation of CAM: purchase chicken embryos of appropriate age, incubate to 9 days old, check and discard defective chicken embryos. Mark the air chamber position on the surface of the normal chicken embryo eggshell, peel off part of the eggshell, and expose the white egg membrane; carefully remove the inner membrane with tweezers to ensure that the blood vessel membrane is not damaged.

[0066] Irritation scoring method: 6 chicken embryos per group, 0.3 mL of sample is directly added to the surface of CAM, the reaction of CAM is observed, the time of bleeding, coagulation and vascular fusion is recorded within 5 min, and the degree of reaction is recorded.

[0067] End-point evaluation method: 6 chicken embryos per group, 0.3 mL of sample is directly added to the surface of CAM, the reaction of CAM is observed, and after 3 min of action, the test substance is removed by gently washing with normal saline, and the bleeding, coagulation and vascular fusion reactions and their degrees are observed within 30 s after washing. If the observation shows that at least one reaction of all 6 chicken embryos is scored as moderate or above (total score ≥12), the experiment should be repeated once.

[0068] Positive and negative controls (negative control (NC): 0.9% NaCl; positive control (PC): 0.1 mol / L NaOH) were added, and the positive and negative controls were operated by stimulation scoring method. The sample was operated by end-point scoring method, and the results are shown in Tables 4-5 and Figs. 1-3 .

[0069] Table 4 Score results of control group

[0070]

[0071] Table 5 Score results of test sample

[0072]

[0073] The experimental results show that the tightening repair gel agent does not cause obvious irritation reaction in the chicken embryo mucosa irritation test, proving that it is mild and non-irritating to mucosa tissue.

[0074] Finally, it should be noted that the above examples are intended to illustrate the technical solutions of the present application rather than limit the protection scope of the present application. Although the present application has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present application can be modified or replaced by equivalents without departing from the essence and scope of the technical solutions of the present application.

Claims

1. A gynecological gel with vaginal tightening effect, characterized in that, Based on 100 parts by weight, the gelling agent comprises the following components in parts by weight: 0.1-1 parts gallic acid, 0.2-1 parts dimethyl sulfone, 1.5-5 parts humectant, 0.1-1 parts thickener, 0.2-0.5 parts neutralizer, and the balance being water; The humectant comprises glycerin and 1,2-hexanediol; the mass ratio of glycerin to 1,2-hexanediol is (1.5-2.5):1; the thickener comprises carbomer U30; the neutralizing agent comprises sodium hydroxide; The mass ratio of gallic acid to dimethyl sulfone is 1:(1-2).

2. The gynecological gel as described in claim 1, characterized in that, The gelling agent, based on 100 parts by weight, comprises the following components in parts by weight: 0.1-0.4 parts gallic acid, 0.2-0.5 parts dimethyl sulfone, 1.5-5 parts humectant, 0.1-1 part thickener, 0.2-0.5 parts neutralizer, and the balance being water.

3. The gynecological gel as described in claim 2, characterized in that, The gelling agent, based on 100 parts by weight, comprises the following components in parts by weight: 0.2 parts gallic acid, 0.4 parts dimethyl sulfone, 3 parts humectant, 0.5 parts thickener, 0.2-0.5 parts neutralizer, and the balance being water.

4. The method for preparing the gynecological gel according to any one of claims 1-3, characterized in that, The preparation method includes the following steps: S1. Add the thickener to water to allow it to swell, resulting in a swollen solution; S2. Mix the humectant, gallic acid, dimethyl sulfone and water to obtain a mixture, then add the mixture to the swelling solution and stir for 10-30 minutes. S3. Add a neutralizing agent and adjust the pH value to 5.0-6.2 to obtain the gynecological gel.

5. The use of the gynecological gel as described in any one of claims 1-3 in the preparation of vaginal tightening or repair products.

6. The application as described in claim 5, characterized in that, The gynecological gel has a mass percentage content of 0.05-0.15% in vaginal tightening or repair products.

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